Milciclib in Combination With Gemcitabine in Advanced NSCLC

NSCLC Clinical Trial

Official title: Milciclib in Combination With Gemcitabine in Advanced Non-Small Cell Lung Cancer

Status Not yet recruiting

Clinical Trial Summary

The goal of this interventional clinical study is to evaluate the safety and efficacy of Milciclib plus gemcitabine in the treatment of persons with advanced NSCLC. This is an open label uncontrolled clinical trial Eligible patients will receive 150 mg/day of milciclib orally using the 7 days on/7 days off schedule in combination with gemcitabine at the dose of 1000 mg/m² on Days 1, 8, and 15 every 4 weeks. Treatment cycles will be repeated every 4 weeks until progressive disease (radiologic or symptomatic deterioration), the start of a new systemic anticancer therapy, unacceptable toxicity, withdrawal per investigator's judgment, or withdrawal of consent, whichever occurs first.

Clinical Trial Description

This study is a multicenter, prospective, non-randomized, open-label, single-arm Phase 2 study in locally advanced non-resectable recurrent and/or metastatic KRAS-mutated NSCLC after failure of at least 1 line of SoC therapy. All patients will be screened for KRAS mutation status. A total of up to 28 patients harboring G12A, G12D, G12F, G12R, G12S, G12V, or G13D KRAS mutations, or, any pathogenic KRAS mutation other than G12C mutations will be enrolled and treated. According to the Simon's 2-stage design, 13 patients will be treated at Stage 1 with up to 15 patients treated at Stage 2. At the completion of Stage 1, a review of the tumor response evaluation will be undertaken to determine if the second stage should be conducted. If there are 2 or more patients with a complete response (CR) or partial response (PR) in the first 13 patients, an additional 15 patients will be accrued. Stage 1 will be considered complete when all patients have experienced progressive disease (radiologic or symptomatic deterioration), started a new systemic anticancer therapy, have withdrawn per investigator's judgment or experienced unacceptable toxicity, have withdrawn consent, or have completed 6 cycles of treatment. In addition, Stage 1 patients who, at the time of transition to Stage 2, were responding with a CR, PR, or stable disease, will be allowed to continue in the study at the recommended Phase 2 dose; or lower for safety reasons). These patients will not be part of the 15 new patients to be targeted in Stage 2, because they will have already received treatment with milciclib plus gemcitabine in Stage 1, but they will provide additional safety information regarding prolonged treatment with milciclib plus gemcitabine ;

Related Conditions & MeSH terms

• NSCLC

• NCT number: NCT05651269
• Study type: Interventional
• Source: Tiziana Life Sciences LTD
• Contact: John Andrews, PhD
• Phone: 910-232-8932
• Email: jandrews@TizianaLifeSciences.com
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 15, 2023
• Completion date: June 2025